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OpenTrials
Completed

NCT Number: NCT02533089

Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi

Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers. Despite availability of effective treatment, tuberculosis (TB) remains an important cause of mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In response to the combined high TB burden and severe healthcare worker shortages in these settings, outpatient TB care is among the tasks commonly shifted to LHWs.

LHWs are community members who have received some training but are not healthcare professionals. Randomised trials show LHWs improve access to basic health services and TB treatment outcomes, however, insufficient training and supervision are recognized barriers to their effectiveness.

The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of evidence into LHW practice. The investigators will employ a mixed methods design including a pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and qualitative methods to understand barriers and facilitators to scalability and sustainability of the program.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

4 Districts, SE zone of Malawi (Balaka, Machinga, Mangochi, Mulanje)

Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all health centers in participating districts that routinely provide TB care will be included.
  • LHWs who have received the intervention and patients receiving care at participating health centers will be eligible to participate in interviews

Exclusion criteria

  • health centers that do not routinely provide TB care
  • LHWs unwilling or unable to give informed consent.
  • TB patients less than 18 years of age unaccompanied by a parent or guardian, patients/guardians or LHWs unwilling or unable to give informed consent, patients presenting to a health center they are not routinely followed at.

Treatment and study plan

KT intervention

Other

Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.

Primary outcomes

  1. Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.

    Time frame: 1 year

    primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.

Secondary outcomes

  1. Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)

    Time frame: 1 year

    secondary outcome =proportion of default cases (treatment interrupted >= 2 consecutive months)

  2. Proportion of Successes Among HIV Co-infected Cases

    Time frame: 1 year

    secondary outcome = proportion of successes among HIV co-infected cases

Sponsors and collaborators

Lead sponsor

Dignitas International

Other

Collaborators

  • Unity Health Toronto

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 26, 2015
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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